There exists a general need to inject two or more medicaments simultaneously. Examples of medicaments are medicaments containing insulin, an insulin analog or an insulin derivative, GLP-1 or a GLP-1 analog, an analgesics, a hormone, a beta agonist or a corticosteroid or a combination of any of the above-mentioned active pharmaceutical ingredient per se (API) or in a dry, solid or liquid formulation further comprising one or more suitable excipients. Suitable excipients for this purpose are e.g. water, glycerol, polyols (mannitol, xylitol), macrogol or mono-, di-, oligo- or polysaccharides (e.g glucose, fructose, saccharose, dextrates, dextran 40).
For the purposes of our invention the term “insulin” shall mean Insulin, insulin analogs, insulin derivatives or mixtures thereof, including human insulin or a human insulin analogs or derivatives. Examples of insulin analogs are, without limitation, Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin or Des(B30) human insulin. Examples of insulin derivatives are, without limitation, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
As used herein the term “GLP-1” shall mean GLP-1, GLP-1 analogs, or mixtures thereof, including without limitation, exenatide (Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2), Exendin-3, Liraglutide, or AVE0010 (H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Ser-Lys-Lys-Lys-Lys-Lys-Lys-NH2).
Examples of beta agonists are, without limitation, salbutamol, levosalbutamol, terbutaline, pirbuterol, procaterol, metaproterenol, fenoterol, bitolterol mesylate, salmeterol, formoterol, bambuterol, clenbuterol, indacaterol.
Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
As just one example, certain disease states require treatment using one or more different medicaments. For example, in some cases it might be beneficial to treat a certain diabetic with a long acting insulin along with a glucagon-like peptide-1 (GLP-1) or a GLP-1 analog, which is derived from the transcription product of the proglucagon gene. GLP-1 is found in the body and is secreted by the intestinal L cell as a gut hormone. GLP-1 and GLP-1 analogs possess several physiological properties that make it (and its analogs) a subject of keen investigation as a potential treatment of diabetes mellitus.
Delivering at least two medicaments simultaneously can create a number of concerns for a medical delivery device provider as well as for the user of the device. As just one example, the medicaments may interact with each other during the long-term storage of the formulation. Therefore, it may be advantageous to store the medicaments separately and then only combine these active components at a later point in time, such as the time of medicament administration. That is, in some arrangements, during either injection or during inhalation. However, from the standpoint of the user, combining medicaments should be patient friendly and convenient so as to result in reliable dose selection and dose injection.
A further potential concern is that the quantities and/or proportions of each medicament making up the combination therapy may need to be varied for each user or at different stages of their therapy. For example one or more medicament may require a titration period to gradually increase a patient up to a “maintenance” dose. A further example would be if one medicament requires a non-adjustable fixed dose while the other agent is varied in response to a patient's symptoms, physical condition or other patient criteria. This concern means that pre-mixed formulations of multiple active agents may not be suitable as these pre-mixed formulations would have a fixed ratio of the first and second active components, which could not be varied by the healthcare professional or patient.
Accordingly, there exists a general need to provide devices and methods for the joint delivery of two or more medicaments. According to at least one embodiment, the present apparatus and method overcomes the above-mentioned concerns by providing a solution to the above-described problems by providing an improved cannula assembly and associated injection device having a cannula that has a reservoir containing an active medication. This cannula is part of a cannula assembly that is attached to an injection device, such as a pen injection device containing a cartridge. These and other advantages will become evident from the following more detailed description of the invention. The general problem to be solved by the present invention is to provide a needle assembly where an administration of at least two medicaments is facilitated.